MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION MOSAIC; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 305U

Device Problem Occlusion Within Device (1423)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that 6 years and 1 month post implant of this 21mm mitral bioprosthetic valve, the valve was explanted and replaced with 23mm valve of a different model due to stenosis of the bioprosthetic valve. no additional adverse patient effects were reported.

• Brand Name: MOSAIC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7038501
• MDR Text Key: 92278707
• Report Number: 2025587-2017-02152
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00885074253220
• UDI-Public: 00885074253220
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2014
• Device Model Number: 305U
• Device Catalogue Number: 305U21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/16/2017
• Date Device Manufactured: 07/15/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR